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| Name | Class |
|---|---|
| Migraine Research Foundation | OTHER |
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Ketorolac is an evidence-based, first-line acute migraine therapy that is commonly used in the pediatric population; however, it is typically administered by the intravenous (IV) or intramuscular (IM) routes, both of which require a painful and distressing needle stick to administer.
The intranasal (IN) route is a painless and effective way of administering analgesics, including ketorolac: IN ketorolac has been shown to be an effective analgesic in adults for painful conditions, including acute migraine headaches. However, IN ketorolac has been understudied in children, and it is not known how effective it is compared to IV ketorolac, which is currently the most common way of administering ketorolac to children. If IN ketorolac is shown to be no less effective than IV ketorolac, IN ketorolac may be a viable and painless alternative to effectively treat acute migraine headaches in children.
Therefore, our primary aim is to demonstrate that IN ketorolac is non-inferior to IV ketorolac for reducing pain in children with acute migraine headaches.
Primary Aim: Determine whether intranasal (IN) ketorolac is non-inferior to intravenous (IV) ketorolac for reducing pain in children with acute migraine headaches. We hypothesize that IN ketorolac is non-inferior to IV ketorolac in reducing acute migraine headache pain by a minimum clinically significant difference within 60 minutes of administration.
Secondary Aim: Determine whether there is a difference in time to achieve a clinically significant reduction in pain after receiving IN ketorolac compared to IV ketorolac. We hypothesize that there is no difference between IN ketorolac and IV ketorolac in the time it takes to achieve a clinically significant reduction in pain.
We will conduct a prospective, double-blinded, randomized, non-inferiority, parallel 1:1 clinical trial of eligible children in a single urban pediatric ED. We will block randomize patients to receive either 1 mg/kg IN ketorolac and an IV placebo (study group A), or 0.5 mg/kg IV ketorolac and an IN placebo (study group B).
We will assess the patient's pain at baseline, and then at 10 minutes, 30 minutes and 60 minutes after administration of the study drug. The patient will then be assessed at 2 hours and 24 hours after study drug administration for outcomes related to efficacy, function, and safety.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketorolac, intranasal | Experimental |
|
|
| Ketorolac, intravenous | Active Comparator |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketorolac, intranasal | Drug | Ketorolac 1 mg/kg, maximum dose 30 mg. To be administered by intranasal route. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain Score After Analgesic Administration (Faces Pain Scale - Revised (FPS-R) | Measure the change in pain score after administration of analgesic using the Faces Pain Scale - Revised (FPS-R) at 60 minutes after analgesic administration. The FPS-R is scored from 0 (no pain) to 10 (maximum pain intensity, i.e. worst outcome). | 60 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Achieve Clinically Significant Reduction in Pain After Analgesic Administration (Pain Score) | Pain score will be assessed at 10, 30, 60 and 120 minutes after analgesic administration, until pain score decreases by 2/10 on the Faces Pain Scale - Revised (FPS-R). The FPS-R is scored from 0 (no pain) to 10 (maximal pain, i.e. worst outcome) | 10, 30, 60 and 120 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Adverse events will be assessed at the 1- and 2-hour assessments and the 24-hour follow up. | 24 hours |
| Number of Participants Who Received Rescue Medications During Emergency Department Visit |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel S Tsze, MD, MPH | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NewYork Presbyterian Morgan Stanley Children's Hospital | New York | New York | 10032 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ketorolac, Intranasal |
Ketorolac, intranasal: Ketorolac 1 mg/kg, maximum dose 30 mg. To be administered by intranasal route. Placebo, intravenous: Placebo of equal volume to IV ketorolac, to be administered by intravenous route. |
| FG001 | Ketorolac, Intravenous |
Ketorolac, intravenous: Ketorolac 0.5 mg/kg, maximum dose 30 mg. To be administered by intravenous route. Placebo, intranasal: Placebo of equal volume to IN ketorolac, to be administered by intranasal route. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ketorolac, Intranasal |
Ketorolac, intranasal: Ketorolac 1 mg/kg, maximum dose 30 mg. To be administered by intranasal route. Placebo, intravenous: Placebo of equal volume to IV ketorolac, to be administered by intravenous route. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Pain Score After Analgesic Administration (Faces Pain Scale - Revised (FPS-R) | Measure the change in pain score after administration of analgesic using the Faces Pain Scale - Revised (FPS-R) at 60 minutes after analgesic administration. The FPS-R is scored from 0 (no pain) to 10 (maximum pain intensity, i.e. worst outcome). | Posted | Mean | 95% Confidence Interval | units on a scale | 60 minutes |
|
24 hours after discharge from emergency department.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ketorolac, Intranasal |
Ketorolac, intranasal: Ketorolac 1 mg/kg, maximum dose 30 mg. To be administered by intranasal route. Placebo, intravenous: Placebo of equal volume to IV ketorolac, to be administered by intravenous route. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Daniel Tsze MD MPH | Columbia University | 212-317-0997 | dst2141@cumc.columbia.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 25, 2021 | Nov 26, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| D006261 | Headache |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D020910 | Ketorolac |
| D020911 | Ketorolac Tromethamine |
| ID | Term |
|---|---|
| D007213 | Indomethacin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Ketorolac, intravenous | Drug | Ketorolac 0.5 mg/kg, maximum dose 30 mg. To be administered by intravenous route. |
|
|
| Placebo, intravenous | Drug | Placebo of equal volume to IV ketorolac, to be administered by intravenous route. |
|
| Placebo, intranasal | Drug | Placebo of equal volume to IN ketorolac, to be administered by intranasal route. |
|
Rescue medication defined as an additional parenteral analgesic administered in response to inadequate improvement in pain. Rescue medication was administered when deemed clinically indicated by the treating clinician.
| 12 hours |
| Number of Participants Who Experienced Headache Relief During Emergency Department Visit | Headache relief defined as change of the patient's headache pain intensity from severe to moderate to either mild or none, without receipt of rescue medications. | 2 hours |
| Number of Participants Who Experienced Headache Freedom During Emergency Department Visit | Headache freedom defined as achieving a headache pain intensity of "none", without receipt of rescue medications. | 2 hours |
| Percentage Change in Pain Score Between Baseline and One Hour | Percentage change in pain score between baseline and one hour after study medication administration. Pain measured using the Faces Pain Scale - Revised (FPS-R), which is scored from 0 (no pain) to 10 (maximum pain intensity, i.e. worst outcome). Positive values (i.e. percentage change) indicate a DECREASE (i.e. improvement) in pain intensity. | 1 hour |
| Number of Participants Who Reported Positive Overall Efficacy and Tolerability at 24-hour Follow-up | Patient's assessment of overall efficacy and tolerability was assessed by asking the question, "The next time you come to the emergency department with a headache or migraine, do you want to be given the same medication?". A "yes" response was considered positive assessment of overall efficacy and tolerability. | 24 hours |
| Number of Participants Who Reported Sustained Headache Freedom at 24-hour Follow-up | Sustained headache freedom defined as achieving headache freedom (i.e. headache pain intensity of "none"), and maintaining this level for 24 hours without the use of rescue medications after emergency department discharge. | 24 hours |
| Number of Participants Who Reported Sustained Headache Relief at 24-hour Follow-up | Sustained headache relief defined as achieving headache relief (i.e. headache pain intensity of "mild" or "none") and maintaining this level for 24 hours without the use of rescue medications after emergency department discharge. | 24 hours |
| Number of Participants Who Used Rescue Medication(s) Within 24 Hours After Emergency Department Discharge | Rescue medications used after emergency department discharged defined as an analgesic taken by the participant at home to reduce pain associated with their headache. | 24 hours |
| BG001 |
| Ketorolac, Intravenous |
Ketorolac, intravenous: Ketorolac 0.5 mg/kg, maximum dose 30 mg. To be administered by intravenous route. Placebo, intranasal: Placebo of equal volume to IN ketorolac, to be administered by intranasal route. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
Ketorolac, intravenous: Ketorolac 0.5 mg/kg, maximum dose 30 mg. To be administered by intravenous route. Placebo, intranasal: Placebo of equal volume to IN ketorolac, to be administered by intranasal route. |
|
|
| Secondary | Time to Achieve Clinically Significant Reduction in Pain After Analgesic Administration (Pain Score) | Pain score will be assessed at 10, 30, 60 and 120 minutes after analgesic administration, until pain score decreases by 2/10 on the Faces Pain Scale - Revised (FPS-R). The FPS-R is scored from 0 (no pain) to 10 (maximal pain, i.e. worst outcome) | Posted | Mean | 95% Confidence Interval | Minutes | 10, 30, 60 and 120 minutes |
|
|
|
| Other Pre-specified | Adverse Events | Adverse events will be assessed at the 1- and 2-hour assessments and the 24-hour follow up. | Posted | Count of Participants | Participants | 24 hours |
|
|
|
| Other Pre-specified | Number of Participants Who Received Rescue Medications During Emergency Department Visit | Rescue medication defined as an additional parenteral analgesic administered in response to inadequate improvement in pain. Rescue medication was administered when deemed clinically indicated by the treating clinician. | Posted | Count of Participants | Participants | 12 hours |
|
|
|
| Other Pre-specified | Number of Participants Who Experienced Headache Relief During Emergency Department Visit | Headache relief defined as change of the patient's headache pain intensity from severe to moderate to either mild or none, without receipt of rescue medications. | Posted | Count of Participants | Participants | 2 hours |
|
|
|
| Other Pre-specified | Number of Participants Who Experienced Headache Freedom During Emergency Department Visit | Headache freedom defined as achieving a headache pain intensity of "none", without receipt of rescue medications. | Posted | Count of Participants | Participants | 2 hours |
|
|
|
| Other Pre-specified | Percentage Change in Pain Score Between Baseline and One Hour | Percentage change in pain score between baseline and one hour after study medication administration. Pain measured using the Faces Pain Scale - Revised (FPS-R), which is scored from 0 (no pain) to 10 (maximum pain intensity, i.e. worst outcome). Positive values (i.e. percentage change) indicate a DECREASE (i.e. improvement) in pain intensity. | Posted | Mean | 95% Confidence Interval | percentage of initial pain intensity | 1 hour |
|
|
|
| Other Pre-specified | Number of Participants Who Reported Positive Overall Efficacy and Tolerability at 24-hour Follow-up | Patient's assessment of overall efficacy and tolerability was assessed by asking the question, "The next time you come to the emergency department with a headache or migraine, do you want to be given the same medication?". A "yes" response was considered positive assessment of overall efficacy and tolerability. | Posted | Count of Participants | Participants | 24 hours |
|
|
|
| Other Pre-specified | Number of Participants Who Reported Sustained Headache Freedom at 24-hour Follow-up | Sustained headache freedom defined as achieving headache freedom (i.e. headache pain intensity of "none"), and maintaining this level for 24 hours without the use of rescue medications after emergency department discharge. | Posted | Count of Participants | Participants | 24 hours |
|
|
|
| Other Pre-specified | Number of Participants Who Reported Sustained Headache Relief at 24-hour Follow-up | Sustained headache relief defined as achieving headache relief (i.e. headache pain intensity of "mild" or "none") and maintaining this level for 24 hours without the use of rescue medications after emergency department discharge. | Posted | Count of Participants | Participants | 24 hours |
|
|
|
| Other Pre-specified | Number of Participants Who Used Rescue Medication(s) Within 24 Hours After Emergency Department Discharge | Rescue medications used after emergency department discharged defined as an analgesic taken by the participant at home to reduce pain associated with their headache. | Posted | Count of Participants | Participants | 24 hours |
|
|
|
| 0 |
| 27 |
| 0 |
| 27 |
| 5 |
| 27 |
| EG001 | Ketorolac, Intravenous |
Ketorolac, intravenous: Ketorolac 0.5 mg/kg, maximum dose 30 mg. To be administered by intravenous route. Placebo, intranasal: Placebo of equal volume to IN ketorolac, to be administered by intranasal route. | 0 | 29 | 0 | 29 | 6 | 29 |
| Dizziness | Nervous system disorders | Systematic Assessment |
|
| Sleepiness | Nervous system disorders | Systematic Assessment |
|
| Other | Nervous system disorders | Systematic Assessment | "Feeling cold", "less focus, feel off", transient extremity sensory complaints. |
|
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| D009422 | Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006571 | Heterocyclic Compounds |